BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM SURGICAL MATRIX PSMX

    MDR report key: 2892185 · Received December 21, 2012

    Report

    Report Number
    3005920706-2012-00016
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ACELL INC.
    Product Code
    FTM
    PMA / PMN Number
    K041140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACELL HAS SPOKEN TO SURGEON AND REVIEWED RELEVANT MEDICAL RECORDS. BASED ON IT'S REVIEW, ACELL IS NOT AWARE OF ANY CLINICAL OR PATHOLOGICAL EVIDENCE INDICATING IT'S PRODUCT WAS RELATED TO THE NEED FOR EXPLANT. THIS MDR IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. DEVICE WAS USED IN AN OFF LABEL PROCEDURE. THE SAFETY AND EFFECTIVENESS OF THE USE OF THE DEVICE AS AN ADHESION BARRIER AND FOR SUTURE LINE REINFORCEMENT HAVE NOT BEEN DEMONSTRATED AND THERE IS NO FDA CLEARANCE/APPROVAL FOR THESE APPLICATIONS. ACELL IS IN THE PROCESS OF CONTINUING IT'S COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    MORBIDLY OBESE PATIENT WAS IMPLANTED WITH MATRISTEM SURGICAL MATRIX PSMX ON (B)(6) 2012 TO PREVENT ADHESIONS BETWEEN THE LIVER AND STOMACH AND FOR SUTURE LINE REINFORCEMENT IN A HIATAL HERNIA REPAIR PROCEDURE. AT AN UNDISCLOSED TIME, PATIENT REPORTED ABDOMINAL PAIN. THE PATIENT WAS TAKEN BACK TO SURGERY AND THE DEVICE WAS EXPLANTED ON (B)(6) 2012. DURING THIS FOLLOW-UP SURGERY, THE ADHESIONS OF THE OMENTUM AND BOWEL IN THE LEFT UPPER QUADRANT OF ABDOMEN WERE LYSED. IN ADDITION, PATIENT WAS NOTED TO HAVE A CYSTIC MASS IN THE LEFT UPPER QUADRANT. THIS MASS WAS DRAINED. THERE WAS NO EVIDENCE OF INFECTION OR BACTERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRISTEM SURGICAL MATRIX PSMX FTM, SURGICAL MESH FTM ACELL INC. SM2221-61

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R VALIUM| PROTONIX| LEVOTHYROXINE| SODIUM| SODIUM| GARLIC TABLET| LIOTHYRONINE